Quality Controller

JR United Kingdom; Oxford; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading company in medical devices is looking for a Quality Assurance professional in Oxford. The role involves ensuring compliance through QA/QC functions, product inspections, and maintaining quality documentation. Candidates should have experience in manufacturing, particularly in the medical device industry, and possess good communication and organizational skills.

Qualifications

• Experience in a manufacturing environment (medical device preferred).
• Ability to read and analyze drawings and procedures.
• Knowledge of ISO13485 & FDA QSR is a plus.

Responsibilities

• Conduct QA/QC functions, prioritize demands, report deviations.
• Product release planning and inspection/testing.
• Maintain a compliant Quality Management System documentation.

Skills

Attention to Detail

Organizational Skills

Time Management

Communication Skills

Education

5 GCSEs or equivalent including Maths/English

Job description

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AMS is a world-leading independent developer and manufacturer of innovative tissue-healing technology, focused on quality outcomes for patients and value for payers. AMS has a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices and internal sealants, which it markets under its brands LiquiBand, RESORBA, LiquiBandFix8, LIQUIFIX, Peters Surgical, Ifabond, Vitalitec and Seal-G. AMS also supplies wound care dressings such as silver alginates, alginates, and foams through its ActivHeal brand as well as under white label. Since 2019, the Group has made seven acquisitions: Sealantis, Biomatlante, Raleigh, AFS Medical, Connexicon, Syntacoll, and Peters Surgical. AMS's products are manufactured in multiple countries and sold globally via various channels. The Group has R&D hubs in the UK, Ireland, Germany, France, and Israel, and was established in 1991 with over 1,500 employees.

AMS provides equal employment opportunities and values diversity across its workforce, ensuring no discrimination based on gender, race, age, nationality, disability, or other protected characteristics.

Role Responsibilities:

• Conduct QA/QC functions, prioritize demands, work according to SOPs and PWIs, report non-conformances or deviations.
• Product release planning, performing goods receiving inspection & testing, in-process inspection and testing, final product release.
• Develop, generate, maintain, and audit documentation supporting an effective and compliant Quality Management System, including Device History Records, Material and Product Specifications, Test Records, and In-process & product release testing.
• Update and maintain quality procedures, test methods, and instructions. Train others as required.

Qualifications and Skills:

• Experience in a manufacturing environment (medical device preferred), with appropriate qualifications (5 GCSEs or equivalent including Maths/English).
• Ability to read, analyze, and understand drawings, procedures, and standards.
• Ability to represent the department in cross-functional interactions.
• Desirable: Experience in medical device industry, knowledge of ISO13485 & FDA QSR, City & Guilds 743 or equivalent, statistical knowledge, knowledge of quality techniques, GMP, GCP, and quality systems.
• Strong attention to detail, organizational skills, effective time management, and good communication skills. Flexible and adaptable to changing environments.